ARTOURA Breast Tissue Expander TEXP130RHRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00081317009474), received between Oct 17, 2018 and Mar 28, 2024 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (6 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 47-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH 475CC ARTOURA BREAST TISSUE EXPANDER AND EXPERIENCED WOUND INFECTION ON HER LEFT SIDE POSTOPERATIVELY. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. THE PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY WITH CATALOG NUMBER 3502700; SERIAL NUMBER (B)(6) ON THE LEFT SIDE, AND WITH CATALOG NUMBER 3502700; SERIAL NUMBER (B)(6) ON THE RIGHT SIDE ON (B)(6) 2024.

  Patient problems: Post Operative Wound Infection

  MAUDE report 18999368 ↗
• MalfunctionNov 9, 2023Connection Problem; Connection Problem

  IT WAS REPORTED THAT A 475CC ARTOURA BREAST TISSUE EXPANDER AND AN UNKNOWN MENTOR TISSUE EXPANDER WERE OBSERVED TO HAVE DEFECTIVE VALVES PRIOR TO AN UNSPECIFIED BREAST SURGERY. HOWEVER, THE SURGERY COMMENCED WITHOUT ANY REPORTED DELAYS AND A NEW IMPLANT WAS USED TO COMPLETE THE IMPLANTATION. NO REPORTED ADVERSE EVENTS OR PATIENT OUTCOMES WERE REPORTED. THIS REPORT IS FOR THE FIRST OF TWO IMPLANTS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-13351 FOR THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18107258 ↗
• InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH 475CC ARTOURA BREAST TISSUE EXPANDER EXPERIENCED RIGHT-SIDED SOFT TISSUE NECROSIS POSTOPERATIVELY. THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH 475CC SMOOTH MENTOR MEMORYGEL BREAST IMPLANT, CATALOG # 3504754BC, RIGHT LOT-SERIAL # (B)(4) ON (B)(6) 2016. UPON EXPLANTATION, THE RIGHT BREAST WAS NOTED TO HAVE AN AREA OF OLD HEMATOMA AND POSSIBLE NECROTIC PECTORALIS MUSCLE.

  Patient problems: Necrosis

  MAUDE report 11159380 ↗
• InjuryAug 20, 2020Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST RECONSTRUCTION WITH 475CC ARTOURA BREAST TISSUE EXPANDER EXPERIENCED POSTOPERATIVE LEFT-SIDED TISSUE EXPANDER DEFLATION. THE PHYSICIAN SUSPECTED DEFLATION UPON PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2020. FURTHERMORE, OFF-LABEL USE OF THE DEVICE WAS NOTED AS TISSUE EXPANDERS ARE NOT INTENDED FOR USE BEYOND SIX MONTHS.

  Patient problems: No Code Available

  MAUDE report 10434032 ↗
• InjuryJan 17, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 475CC MENTOR ARTOURA BREAST TISSUE EXPANDER AND EXPERIENCED POSTOPERATIVE DEFLATION. AS A RESULT, THE PATIENT'S IMPACTED DEVICE WAS EXPLANTED ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 9603704 ↗
• InjuryJan 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, ARTOURA BREAST TISSUE EXPANDER 475CC WAS RECEIVED BY THE MENTOR FAILURE ANALYSIS LAB WITH NO ACCOMPANYING INFORMATION. THE DEVICE COULD NOT BE ASSOCIATED WITH AN EXISTING COMPLAINT. IN THE ABSENCE OF CLARIFYING INFORMATION, IT CANNOT BE DETERMINED WHY THIS DEVICE WAS RETURNED TO MENTOR. HOWEVER, IT WILL BE CONSERVATIVELY REPORTED TO FDA AS AN EVENT REQUIRING MEDICAL DEVICE REMOVAL FROM A PATIENT.

  Patient problems: No Code Available

  MAUDE report 9592436 ↗
• InjuryDec 23, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH ARTOURA BREAST TISSUE EXPANDER 475CC AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED BY A PHYSICIAN. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH UNSPECIFIED MENTOR IMPLANTS ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 9512084 ↗
• InjuryDec 10, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT BREAST SURGERY WITH AN ARTOURA BREAST TISSUE EXPANDER 475CC DEVICE THAT DEFLATED AFTER IMPLANTATION. IT WAS OBSERVED DURING EXCHANGE SURGERY ON (B)(6) 2019 THAT THE LEFT SIDE TISSUE EXPANDER WAS DEFLATING AROUND THE PORT. THE DEFLATED EXPANDER WAS REPLACED WITH AN UNSPECIFIED BREAST PROSTHESIS.

  Patient problems: No Code Available

  MAUDE report 9446220 ↗
• InjurySep 11, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) ASIAN FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 475CC ARTOURA BREAST TISSUE EXPANDER EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. THE DEFLATION WAS CONFIRMED BY A PHYSICIAN. AS A RESULT, BILATERAL EXPLANT WITH UNKNOWN REPLACEMENT STATUS WAS PERFORMED ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8998288 ↗
• InjuryOct 17, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR ARTOURA BREAST TISSUE EXPANDER 475CC DEVICE THAT DEFLATED AFTER IMPLANTATION. THE PATIENT¿S DOCTOR OBSERVED THAT THE LEFT TISSUE EXPANDER WAS LESS FULL. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7976451 ↗